Projects Involving Potentially Hazardous Biological Agents

Some research projects may involve working with potentially hazardous biological agents. Examples are projects that use microorganisms, recombinant DNA (rDNA) technologies, or human or animal fresh tissues, blood, or body fluids. To insure the safety of student researchers and their home and school environments, many fairs require pre-approval of projects involving potentially hazardous biological agents.

Projects Not Requiring Pre-approval

"The following types of tissue do not need to be treated as potentially hazardous biological agents" (Science Service, 2006):

1. Plant tissue
2. Established cell and tissue cultures (e.g., those obtained from the American Type Culture Collection). The source and catalog number of the cultures should be identified in the Research Plan Attachment.
3. Meat or meat by-products obtained from food stores, restaurants, or packing houses
4. Hair
5. Teeth that have been sterilized to kill any blood borne pathogen that may be present. Chemical disinfection or autoclaving at 121 degrees Celsius for 20 minutes is a recommended procedure.
6. Fossilized tissue or archeological specimens
7. Prepared fixed tissue slides.

The following types of studies do not need SRC review, but you will need to complete the Risk Assessment Form:

1. Studies involving baker's yeast and brewer's yeast, except when involved with rDNA studies
2. Studies involving most protists, archae and similar microorganisms
3. Research using manure for composting or other non-culturing experiments and fuel production
4. Studies involving lactobacillus, bacillus thurgensis, nitrogen- fixing, oil-eating bacteria and algae-eating bacteria introduced into their natural environment. (Not exempt if cultured in a petri dish environment that could potentially be contaminated). In addition, naturally-occuring plant pathogens may be studied (not cultured) at home, but may not be introduced into a home/garden environment.

Projects Requiring Pre-Approval

If you are participating in a fair that follows the Intel International Science and Engineering Fair (ISEF) rules, your project involving potentially hazardous biological agents (microorganisms, recombinant DNA (rDNA) technologies, or human or animal fresh tissues, blood, or body fluids) must be reviewed by officials from your fair before you start. These officials are called a Scientific Review Committee (SRC). Often school science fairs and fairs for the primary grades or middle school rely on the teacher's judgment to insure safety, so their rules might be different. For complete information, consult the rules for your local fair, or the ISEF Rules and Guidelines.

Direct Supervision Is Required

For ISEF-affiliated fairs, all experiments involving hazardous biological agents must be carried out under the direct supervision of a competent scientist who understands the risks associated with the agents involved OR an adult designated and trained by that scientist. In ISEF jargon, these adult supervisors are called the Qualified Scientist or the Designated Supervisor. The Qualified Scientist must certify that the Designated Supervisor has been adequately trained and also understands the risks associated with working with the agents involved.

A Risk Assessment Is Required

The student and adults involved in the project are required to think ahead about the possible hazards that the project might involve. This analysis is called a risk assessment. The risk assessment will be reviewed by the SRC as part of the pre-approval process. The goal of your risk assessment is to determine the risk level of the project, which ISEF rules define as "the potential level of harm, injury or disease to plants, animals and humans that may occur when working with biological agents." (Science Service, 2006) The risk level must be determined to be either "low" or "moderate" in order for the project to be approved (high-risk projects are not appropriate for science fairs). In any case, experiments involving potentially hazardous biological agents can not be conducted in a home environment; they must be carried out in a research laboratory setting.

Projects That Can Be Performed in a School Laboratory

Low-risk biological agents are "highly unlikely to cause disease in healthy laboratory workers, animals or plants." (Science Service, 2006) Examples of low-risk organisms are: Aspergillus niger, Bacillus thuringiensis, Escherichia coli strain K12, Lactobacillus acidophilus, Micrococcus leuteus, Neurospora crassa, Pseudomonas fluorescens, Serratia marcescens (Science Service, 2006). These experiments are not to be carried out in the home environment. The following conditions apply to the laboratory setting: "Work is done on an open bench or in a fume hood. Standard microbiological practices are used when working in the laboratory. Decontamination can be achieved by treating with chemical disinfectants or by steam autoclaving. Lab coats are required and gloves recommended. The laboratory work is supervised by an individual with general training in microbiology or a related science." (Science Service, 2006)

Projects That Must Be Performed in a Research Institution

According to the ISEF rules, moderate-risk biological agents are unlikely to spread if exposure occurs in the laboratory, and rarely would cause infection that would lead to serious disease. Effective treatment and preventive measures are available in the event that an infection occurs. Examples of moderate-risk organisms are: Mycobacterium, Streptococcus pneumonia, Salmonella choleraesuis. Projects involving moderate-risk biological agents must be carried out in a professional research setting under the supervision of a competent scientist who understands the risks associated with working with the agents involved. (Science Service, 2006)

A Special Case: Projects Involving Unknown Microorganisms

Another category of concern is studies involving unknown microorganisms. In science fair projects these studies typically involve collecting and culturing microorganisms from the environment (e.g. household surfaces, skin, soil). These studies present a challenge because the identity, concentration and pathogenicity of the cultured agents are unknown. Research with unknown microorganisms can be treated as a low-risk study under the following conditions:

1. "The organism is cultured in a plastic Petri dish (or other standard non-breakable container) and sealed. Other acceptable containment include petro film and doubled heavy duty (2-ply) sealed bags.
2. The experiment involves only procedures in which the Petri dish remains sealed throughout the experiment. (i.e. counting presence of organisms or colonies).
3. The sealed Petri dish is disposed of in the appropriate matter under the supervision of the Designated Supervisor." (Science Service, 2006)

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